The invention relates to an apparatus for providing transcutaneous access to an internal hollow organ, in particular to the stomach, comprising a tubular flexible probe disposable transcutaneously in the hollow organ of a living body, and a rigid sleeve attachable to a section of the probe extending from the body, such that the sleeve engages around this section.
Such an apparatus is disclosed in the German patent DE 195 43 011. In the known apparatus, a tubular flexible probe is introduced into the stomach and passed outwardly through the stomach wall and the abdominal wall. A retention ring at the opposite end of the probe prevents the probe from being extracted from the stomach. A reinforcing sleeve is applied to the section of the probe extending from the body, namely over its outer surface. As little relative shifting as possible should take place between the probe and the applied reinforcement sleeve, which probably results from frictional connection, although the document does not mention this.
The assembly comprising the probe section extending from the body and the reinforcement sleeve provides a transcutaneous access to an interior hollow organ, in this case the stomach. Instruments for example can be introduced into the body through this access. A valve element is provided at the outer end of the reinforcement sleeve to avoid release of the contents of the stomach or intestines or insufflation gas from the hollow organ.
A drawback of this apparatus is that relative motion between the probe section extending from the body and the applied sleeve cannot be excluded. Even if one provides a relatively good frictional connection between the outer surface of the flexible probe and the inner surface of the applied sleeve, it cannot be excluded that a relative movement takes place, for example when coughing which is undesirable.
This fixed frictional connection also greatly impairs the handling when applying the reinforcement sleeve to the probe. The reinforcement sleeve must be slid over the section extending from the body. With high friction, this is difficult and requires irregular sudden movements, so that it is difficult to subsequently correct the seating.
It is therefore an object of the present invention to provide an apparatus by which transcutaneous access can be accomplished in simple manner and with as little trauma as possible to the patient, in particular to ensure a reliable seating of the sleeve attached to the probe.
According to the present invention, this object is achieved in that a clamping device is provided for releasably, but securely connecting the probe to the sleeve, which comprises moveable clamping elements being moveable between a clamping and a non-clamping position.
The sleeve can be slid onto the probe section extending from the body without resistance and can be properly positioned, because the moveable clamping elements can be brought into a non-clamping position. A proper positioning is accomplished in that the probe is slightly drawn out so that its inner ring pushes the stomach wall onto the abdominal wall. After adjusting the proper and desired relative position between the probe and the applied sleeve, the clamping device is actuated and the moveable clamping elements are brought into the clamping position. The clamping effect can be selected such that no relative shifting takes place, even with sudden movements of the patient, for example when coughing.
A releasable, but fixed connection between the outer rigid sleeve and the probe section arranged therein is acheived through the clamping means, so that no relative movement between these two components is possible in clamped condition. The probe need only be cut off to the length of the apparatus, so that the instruments can be introduced via a sleeve-like element, as physicians are accustomed to with trocars. After removing the apparatus from the probe, a sufficiently long section remains extended from the body through which corresponding connections can be made for intragastral feeding or also other connecting elements. If necessary, the apparatus can again be attached to this section.
The probe is exactly aligned, because the sleeve engages around and guides the probe, such that it sits precisely concentrically in the rigid sleeve. The proximal, end face of the probe is also exactly circular, so that no danger exists that instruments can catch on the end edges during insertion, which could be the case if these were deformed to become oval or have another form. This represents a substantial contribution to the reliability of the apparatus.
In a further embodiment of the present invention, a base portion is provided for application of the apparatus to a body surface. The feature has the advantage that an exactly aligned seating of the apparatus is ensured on the body.
In a further embodiment, a valve assembly is provided through which the access produced by the probe is sealingly closed. The feature has the advantage that the apparatus itself comprises this valve assembly, so that no complicated connections need be made on the probe itself, rather the apparatus only needs to be placed upon or slid onto the probe.
In a further embodiment of the present invention, the clamping device comprises moveable clamping elements, which can be applied onto the outer side of the probe. The feature has the advantage that after slipping the apparatus onto the probe, the clamping elements can be applied to the outer side of the probe and a clamping between the apparatus and the probe can be accomplished.
In a further embodiment of the present invention, the moveable clamping elements can be applied over the surface of the outer side of the probe. The feature has the advantage that with the larger surface, a frictional connection is achieved even with a relatively small pressure, where the apparatus is clamped to the probe so as not to be shiftable in axial direction. The clamping device is non-distructive, without damaging the material structure, the form or the outside of the probe. This friction connection can then be enhanced by corresponding surface treatments or by the roughness of the clamping elements.
In a further embodiment of the present invention, the clamping elements include projections, which penetrate into the flexible probe when the clamp is closed, however without altering the lumen in the probe. The feature has the advantage that the projections ensure that the apparatus cannot release from the probe even by unskilled handling or with inadvertent catching of the apparatus on other instruments. With a corresponding flexible material, the projections can penetrate from the outside into the probe without altering the lumen in the probe, so that the entire inner cross-section is also available in the clamped condition as an instrument channel.
In a further embodiment of the present invention, the base portion is formed as a separate component. The feature has the advantage that the application of the apparatus is simplified in that the base is first slid onto the probe extending from the body and the base is then positioned and aligned at a suitable location on the body.
In a further embodiment of the present invention, the base comprises a clamping device. The feature has the advantage, especially combined with the above-mentioned features, that the base can be clamped after its alignment with the probe. Corrections can still be made, which are then easier for the operator to carry out than if the complete apparatus were attached.
In a further embodiment of the present invention, the clamping device comprises two approximately half-shell clamping elements. The feature has the advantage that these clamping elements can be arranged to save space, can engage around a large surface area of the probe and then encompass the probe in clamped condition to be aligned, sealed and supported.
In a further embodiment of the present invention, the clamping device comprises a cam shaft rotatable by an external lever, whose cam engages with at least one of the moveable clamping elements. The feature has the handling advantage that the apparatus can be applied with the clamping device being open, where the position of the lever clearly indicates this open position to the operator. After proper alignment, the lever only needs to be actuated to perform the clamping of the probe. The position of the actuated lever then clearly shows this condition to the operator.
In a further embodiment of the present invention, the base comprises a continuous, channel-like opening in which the clamping elements are arranged to be radially displaceable. The feature has the advantage that the clamping elements are integrated into the base in space-saving manner. The application or insertion of the probe in the open condition is simplified and the probe is clamped by a radial movement into the opening.
In a further embodiment of the present invention, the clamping device comprises a tube piece through which the probe is passed and the moveable clamping elements clamp the tube piece where the probe within the tube is clamped at the same time. This feature has the advantage that the clamping elements do not directly engage with the probe, but with the tube through which the probe is passed. A particularly gentle exertion of clamping force over a large surface results in that the entire tube piece is pressed onto the probe without damaging the probe. With appropriate selection of the surface of the tube material or even with the selection of the material itself, a special clamping effect is achieved which hinders through friction a relative movement between the tube piece and the probe therein.
In a further embodiment of the present invention, the base comprises a flat base plate. The feature has the considerable advantage that a larger surface is placed on the body surface via the base plate, so that the apparatus is properly supported, especially against tipping, on the body surface.
In a further embodiment of the present invention, the sleeve comprises a central channel whose diameter corresponds to the outer diameter of the probe. The feature has the advantage that the probe is exactly aligned and guided in the sleeve over its entire length, so that an exactly round and aligned inner instrument channel results, although the probe itself is made of a flexible material. Even if the probe has a slightly oval or distorted condition due to improper storage or because of excess use, it is again aligned to have an exactly round geometry when introduced into this channel. This ensures that an exactly cylindrical instrument channel results, despite such deformations.
In a further embodiment of the present invention, the sleeve can be closed at the proximal end with a valve assembly. The feature has the advantage that the valve assembly is arranged at a favorable position, also accustomed to operators of trocars, which simplifies the handling of the apparatus in the sense of a trocar sleeve.
In a further embodiment of the present invention, the sleeve comprises a head piece, disposable in sealing manner on the base portion. The feature has the advantage that the apparatus comprises two parts, so that the base portion can initially be applied and clamped to the probe and the headpiece is subsequently attached in sealing manner. After applying the base and clamping with the probe, it is easy to cut off the probe to the corresponding length, then slide on the headpiece, which carries the actual sleeve, and seal the connection Corrections are also possible by simply removing the headpiece, for example if the probe has not been cut off to the proper length.
This feature also simplifies the handling. The handling is also simplified when removing the apparatus after an operation. Initially, the head piece can be removed, where the free section of the probe then extends from the base. This section can then be grasped to ensure that the probe is not inadvertently drawn into the body when withdrawing the base.
In a further embodiment of the present invention, the sleeve comprises an inner tube which can be inserted into the flexible probe. The feature has the advantage that the flexible probe is not only supported and reinforced from the outer sleeve, but additionally through the inner tube inserted therein.
The inner tube additionally protects against the inner space of the flexible probe from being restricted under strong clamping pressure. A higher clamping pressure can then be exerted, such that the material of the flexible probe between the stiff inner tube and the stiff outer sleeve cannot be displaced. This embodiment is of advantage, for example when it is recognized from the beginning that the patient is unsettled or frequently coughs, for example due to smoker""s cough.
In a further embodiment of the present invention, the inner tube extends from the distal side of the base. This feature has the advantage that the inner tube not only reinforces the flexible probe in the section projecting from the body, but also for example into the abdominal wall.
In a further embodiment of the present invention, the inner tube projects to the extent that it reaches into the internal hollow organ. This feature has the advantage that regions of the probe also in the internal organ are exactly aligned in the direction of the inner tube and therefore an exact insertion of stiff instruments is allowed. It can be prevented that the flexible probe directly after entry into the internal organ is bent or deflected out of alignment with the sleeve, for example when the patient turns, which would make the insertion of an instrument more difficult with such bent sections.
In a further embodiment of the present invention, the inner tube extends to a head piece of the apparatus. The feature has the advantage that a straight channel, exactly defined in its inner diameter is formed from the head piece, i.e. the proximal end region of the apparatus where an instrument is inserted. With this inner channel, the instruments can be exactly guided which considerably simplifies the handling, especially the insertion into the probe.
In a further embodiment of the present invention, the moveable clamping elements are biased in the clamping direction and an actuator element is provided through which the clamping elements are moveable into the non-clamping position. This feature has the advantage that the clamping elements as well as the actuator element, in the non-actuated condition, are urged into the clamping position, so that a non-releasable seating of the apparatus on the probe is guaranteed. Should the apparatus then be shifted axially with respect to the probe, the actuator element is actuated and the clamping elements are moved against their biasing, so that the sleeve can be shifted axially with respect to the probe.
This simplifies the handling, because the apparatus can initially be positioned on the abdominal wall relatively loosely, while the clamping elements then provide the mentioned non-releasable seating after releasing the actuator element. Other manipulations can then be carried out at this time, for example cutting off the probe. Finally, the relative seating can be corrected or the probe can be manipulated to exactly position the stomach at the inner side of the abdominal wall.
In a further embodiment of the invention, a fixing device is provided to secure the moveable clamping elements in their clamping position. The feature has the advantage that the mentioned simple handling is made possible, and on the other hand, the fixing device ensures that the moveable clamping elements are fixed in their clamping position. Desired or undesired manipulations on the actuator element then do not result in an inadvertent release of the sleeve from the probe.
In a further embodiment of the present invention, the fixing device comprises a fixing ring which fixes the moveable clamping elements in one angular position and allows rotation in another angular position. This feature has the advantage that the fixing device can be brought into the fixed position or the released position by simple angular movement.
In a further embodiment of the present invention, the base comprises two shell elements rotatable with respect to one another, where one of the shell elements carries the fixing ring. The feature has the advantage that the relatively large shell elements offer a convenient grasping location, for example with the hand of the operator, to carry out the angular movement of the fixing device.
In a further embodiment of the present invention, the clamping elements are arranged on components biased with springs to move toward the probe and the actuator element engages with these components such that the actuation of the actuator element moves the clamping elements against the force of the springs away from the probe. This feature has the advantage that the clamping elements can be moved in a simple procedure, namely by actuating the actuator element.
In a further embodiment of the present invention, at least one window is provided in the headpiece through which the assembly of the probe and the headpiece is visible. This feature has the advantage that the exact seating and the exact assembly, especially in the embodiment with the inner tube, can be visually inspected through the window.
It will be understood that the above-mentioned features and those to be described below are not only applicable in the given combinations, but may also be present in other combinations or taken alone without departing from the scope of the present invention.